Moderate Alcohol Intake Among Patients With Type 2 Diabetes

• Status: Unknown status
• Trial end date: 2006-12-01
• Target enrollment: 0
• Participant gender: All

Summary

Our specific aim is to explore the effect of moderate alcohol intake on parameters of glycemic index and lipid profile among patients with type 2 diabetes.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The S. Daniel Abraham International Center for Health and Nutrition
• Collaborators: Harvard University; Itamar Raz, Hadassah Medical Center, Jerusalem, Israel; Julio Vainstein, Wolfson Medical Center, Holon, Israel; Soroka University Medical Center; The Israeli Diabetes Research Group; Tishbi Wines, Israel and Admiral Wine Imports, US
• Treatments: Ethanol

Criteria

Inclusion Criteria:

1. Age between 40-75 yrs.

2. Alcohol abstainers (less than or equal to 1 drink/week)

3. Established diagnosis of type 2 diabetes.

4. Clinically stable, with no stroke or MI within the last 3 months and no major surgery within the last 3 months.

Exclusion Criteria:

1. Taking Insulin >2 injections /day, or with insulin pump.

2. TGs>500 mg/dL.

3. HbA1c >10%

4. Serum creatinine > 2 mg/dl

5. Liver dysfunction (above 2 fold level of ALT and/or AST enzymes)

5. Evidence of severe diabetes complications (such as proliferative retinopathy or renal disease).

6. Patients with autonomic neuropathy manifested as postural hypertension and/or hypoglycemia unawareness. 7. Using drugs that might significantly interact with moderate alcohol. List of drugs will be obtained from pharmacology expert. 8. Presence of active cancer, receiving or had received chemotherapy in last 3 years.

9. Suffering a major illness that might probably require hospitalization (upon physician's evaluation).

10. Clinically assessed as having high potential of addictive behavior as judged by a validated clinical assessment and/or personal or family history of addiction, alcoholism or alcohol abuse.

11. Severe symptoms during run-in as assessed by the physician. 12. Pregnant or lactating women. 13. Participation in another trial in which active intervention is being received.

-